Are Medical Devices Regulated

Are Medical Devices Regulated?

Are Medical Devices Regulated

Medical devices play a big role in maintaining good health and diagnosing illnesses in the healthcare industry. Many people have questions about how this technology works and are unsure how it’s regulated. Let’s discuss the different types of medical devices and how the government regulates them to ensure the safety and efficacy of use.

Types of medical devices

Medical devices come in various shapes and sizes, and the amount of regulation they are subject to varies greatly. Some medical devices are tightly regulated, while others are not. It is important to understand the different types of medical devices so that you can make an informed decision about the safety and effectiveness of any device. Some popular medical devices that are regulated include

  • Wearables
  • Implants
  • Digital Health
  • Cyber Security
  • Human Factors
  • Product Lifecycle Management
  • UDI
  • 21 CFR 820, 21 CFR Part 11 (820 is quality systems, and part 11 is electronic records and signatures)

It is important to understand the different types of medical devices to make an informed decision about their safety and effectiveness. While some devices are not regulated, others must undergo rigorous clinical trials before approval.

The FDA’s role in regulating medical devices

Overall, the FDA plays an important role in regulating medical devices and ensuring that these devices are safe for consumers. One of the most common issues when discussing the FDA’s role in medical device regulation is how they determine which products they will regulate or not regulate. While there is no clear-cut answer to this question, it is clear that there are many factors involved, such as product type and whether another agency has previously approved it. Another factor is if its use would be widespread without requiring direct supervision from a physician. With all these variables, it can be difficult to know if the FDA regulates any specific product.


FDA regulates each class differently because of the different risks involved. Class 1 devices have no safety or effectiveness data submitted to FDA before they are marketed. Class 2 requires a 510K clearance which requires data on at least one type of device similar to the proposed device; it also requires an indication of why the proposed device is significantly different or substantially equivalent to a legally marketed device. Class 3 has extensive clinical trial data submitted before marketing and includes post-market studies and rigorous quality system regulation by the FDA, including compliance with several provisions.

Examples of class 1 devices include stethoscopes, bandages, and wheelchairs. These are considered class 1 because

  • Low-risk devices that are simple in design
  • Self-register products with the FDA
  • Most are exempt from pre-market requirements
  • QMS normally complies with 21 CRF Part 820 General Controls, though some devices are exempt

Class 2 examples can include ultrasonic diagnostic equipment, x-rays, and needles. They’re considered class 2 if they’re

  • Medium-risk devices that are more complex in design
  • 510(k) pre-market approval process is required for most
  • QMS must comply with 21 CFR Part 820: Special Controls (Design Controls)

Popular class 3 devices include balloon catheters, pacemakers, and heart valves. These devices are the highest class because

  • High-risk devices
  • FDA shall inspect the facility
  • QMS must comply with 21 CFR Part 820Clinical trials likely
  • A malfunction is unacceptable

Each classification determines the regulatory scrutiny a company faces when bringing its products to market. All three categories are required for complete safety and efficacy regarding new devices. However, it’s important to note that not all categories require stringent procedures like high-risk class 3 products.

Importance of accurate classification

As part of obtaining FDA approval, your medical device must be classified. Classification determines the type of applications and pre-market submissions you will need to submit. This also helps you define your regulatory requirements throughout the product lifecycle and establish realistic milestones for commercialization.

The classification task is daunting for most medical device manufacturers because where do you start, and how do you know that the device was assigned the proper classification? Some costly mistakes result from improper classification because you can waste time and money (even more due to unnecessary documentation) if you have it in the wrong classification.

It is, therefore, essential to have an understanding of the FDA’s Classification process so that you can accurately classify your device. This will help you develop an appropriate strategy to demonstrate that the device meets the requirements of the appropriate classification and assure compliance. The classification must also be considered early in the development process and updated as necessary throughout its lifecycle to ensure it remains in compliance.